NIDEK SA
FR-MF-000000493 · France · SUCY-EN-BRIE
NIDEK SA is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Consultation Unit OT-4200.
Among these devices, 12 are declared active.
Devices declared under this manufacturer
- Logiciel de pilotage de la réfraction NIDEK
- ONE-I Plateau hauteur fixe
- ONE-I Plateau à élévation motorisée
- OT-4200
- UP
- UP Mini
- Unité de consultation AFFINITY
- Unité de consultation AFFINITY RT
- Unité de consultation OT-6400
- Unité de consultation SYNETIC
- fauteuil de consultation NIDEK
- unité de consultation LYPOP
Catalogue references include GPC0082, HTA0018, HTA0019/HTA0020/HTA0021/HTA0022/HTA0023/HTA0024/HTA0026, HUC1500, HUC1500F, HUC2210.
European nomenclature codes declared: Q0299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NIDEK CO., LTD. (JP) · FDA 8030392 |
| Devices in EUDAMED | 12 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NIDEK CO., LTD. |
What it holds in Canada
| Licences on record | 45 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 32 |
| Class 3 devices | 13 |
| First licensed | 2001-06-26 |
Licence types: System (20), Device Family (13), Single Device (11), Device Group (1).
Licensed under: NON-CONTACT TONOMETER, NIDEK GREEN LASER PHOTOCOAGULATOR MODEL GYC-10, OPHTHALMIC ND:YAG LASER MODEL YC-1800, HYDROPHOBIC ACRYLIC POSTERIOR CHAMBER INTRAOCU, US-4000 ECHOSCAN, US-500 ECHOSCAN.
North American profile: Both markets. NIDEK SA is registered in both the United States and Canada.